- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07338149
Postoperative Computed Tomography Detection of Syndesmotic Malreduction in Ankle Fractures
Detection of Syndesmotic Malreduction by Postoperative Computed Tomography in Ankle Fractures With Acceptable Radiographs: A Prospective Cohort Study
Study Overview
Status
Conditions
Detailed Description
Accurate reduction of the distal tibiofibular syndesmosis is essential for restoring ankle stability and achieving favorable functional outcomes after ankle fracture fixation. Plain radiographs are routinely used to assess postoperative syndesmotic reduction; however, subtle malreductions may not be detected using standard radiographic views alone.
This prospective observational cohort study includes adult patients with ankle fractures requiring operative fixation and syndesmotic stabilization who demonstrate acceptable postoperative plain radiographs. As part of postoperative evaluation, all included patients undergo computed tomography imaging to provide a more detailed assessment of syndesmotic reduction, particularly with respect to rotational and translational alignment of the distal fibula relative to the tibia.
Based on computed tomography findings, syndesmotic reduction is categorized according to predefined criteria. Functional outcomes are assessed at 12 months postoperatively using the American Orthopaedic Foot and Ankle Society ankle-hindfoot score. The study is observational in nature, and imaging findings do not influence postoperative management or treatment decisions.
The objective of this study is to assess the limitations of plain radiographs in detecting syndesmotic malreduction and to evaluate the association between computed tomography findings and functional outcomes following ankle fracture fixation.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Cairo, Egypt
- Kasr Alainy
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adults aged 18 to 65 years
- Acute ankle fractures requiring operative fixation with syndesmotic stabilization
- Acceptable postoperative plain radiographs based on standard radiographic criteria
- Ability to comply with follow-up and functional assessment
Exclusion Criteria:
- Open ankle fractures
- Previous surgery on the affected ankle
- Polytrauma patients
- Pathological fractures
- Incomplete imaging or follow-up data
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Ankle Fracture Patients With Syndesmotic Fixation
Adult patients with ankle fractures requiring operative fixation and syndesmotic stabilization who demonstrated acceptable postoperative plain radiographs and were followed prospectively for imaging and functional outcome assessment.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Functional outcome assessed by the American Orthopaedic Foot and Ankle Society ankle-hindfoot score
Time Frame: 12 months postoperatively
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Functional outcome of the affected ankle assessed using the American Orthopaedic Foot and Ankle Society (AOFAS) ankle-hindfoot score, which evaluates pain, function, and alignment on a 0-100 point scale, with higher scores indicating better function.
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12 months postoperatively
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Syndesmotic reduction accuracy assessed by postoperative computed tomography
Time Frame: within 1 week after surgery
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Accuracy of distal tibiofibular syndesmotic reduction assessed using postoperative computed tomography imaging, based on predefined radiological criteria evaluating translational and rotational alignment of the distal fibula relative to the tibia.
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within 1 week after surgery
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MS-310-2021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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